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Pro Life thoughts in a pro choice world through the eyes of a convert. I took early retirement after working in the social work and Human Resources fields but remain active by being involved in pro life education, lobbying and speaking .

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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Thursday, December 15, 2011

NextGen: Trusts FDA and young girls but not parents and drs.

University of PA NextGenJournal article takes exception to the HHS Secretary's decision to block OTC sales of the Morning After Pill or Plan B to minors under 17. Some of the amazing points of view decry that the govt. does not trust young girls!!

"The most disheartening aspect of this is the lack of trust the government puts in the decisions of young girls." 

I guess this is spin off of Trust Women.
"By politicizing sex and failing to trust teenagers to make responsible sexual choices, the Health Secretary and the President hurt reproductive justice."
We are talking about girls under the age of 17.....trust women, trust teenagers, trust pre teens, trust the FDA. Recognize the mantra....

Down on the Pharm blogger  Karen Brauer posts a comment about trust and faith that clarifies the matter for NextGen author....
"Should we not be protecting our children from those who think it's OK for 11 year olds to have sex, and buy a drug entity  which is  60 percent effective per use,  which is associated with virilization of female fetuses, increased susceptibility to STDs, and osteoporosis, and is not studied  in the pre-teen population? 

The FDA has "proven" nothing about the safety and efficacy of levonorgestrel 1.5mg  in pre-teens (or any other population).  This is not the function of the FDA.  It has ALSO  largely abandoned the practice of  analyzing evidence to establish sufficient safety and efficacy of  medical entities for the market.  The FDA is not succeeding at too much these days, except paper consumption.
In medical research, we accumulate evidence, but we do not provide proof.  One should never trust the grandiose  medical claims  in which the word "proven" or "proof" is used.

We should also not be placing faith in the FDA, which has mishandled the HUGE shortages of medically vital drugs and chemotherapeutic agents.   Lives have been lost and countless more are at risk because the drug supplies have become so unpredictable  that rational adaptations and substitutions  cannot be made in a timely manner.  Our government has been exacerbating this problem while it diddles with the desires of people who want sexual access  to the pediatric population."


Saturday, September 10, 2011

Influential F.D.A. commissioner dies..first to express concern about safety of bc pills



New York Times run a piece on Dr. Charles C. Edwards. He was the first to express concerns about whether the products actually worked and was concerned about their safety. Does the benefits outweigh the risks? Notice how Planned Parenthood objected to even warnings??
New legislation required the F.D.A. to determine for the first time not only if drugs were safe, but also if they actually worked. Dr. Edwards, who had been appointed commissioner by President Richard M. Nixon in 1969, ordered the review of hundreds of thousands of prescription and over-the-counter drugs. A particularly visible action concerned birth control pills, which were revolutionizing sexual behavior but seemed to be causing worrisome side effects.
He ordered that a message be inserted in each package discussing the pills’ benefits and hazards, including the possibility of blood clots and breast cancer. It was the boldest step yet taken under a 1966 law requiring accurate labeling.
Planned Parenthood objected to the warnings because it believed that the pills’ benefits far outweighed what it said were unproved dangers. At the same time, doctors complained that the action encroached on their role of instructing and guiding patients. Later, Dr. Edwards ordered that two brands of birth control pills be removed from the market as unsafe.

Photo: AP taken in 1970
Dr. Edwards

Friday, July 29, 2011

PP posts emergency warning message on FB...on fake Plan B pills.......

Well, well well.....PP loved the idea of the Plan B, Morning After Pill or Emergency Birth control pill whatever you want to call it being available over the counter. Presently it is available that way.....to 17 and up. See what can happen. They posted this on their Facebook page.
URGENT MESSAGE: EVITAL may be dangerous, do NOT ingest!
http://www.fda.gov/NewsEvents/​Newsroom/PressAnnouncements/uc​m265847.htm

www.fda.gov
The U.S. Food and Drug Administration (FDA) is warning U.S. consumers not to use the emergency birth control medicine labeled as Evital. These products may be counterfeit versions of the “morning after pill” and may not be safe or effective in preventing pregnancy.

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